COLOTAL TABLETS 135 MG

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

MEBEVERINE HYDROCHLORIDE

זמין מ:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

קוד ATC:

A03AA04

טופס פרצבטיות:

TABLETS

הרכב:

MEBEVERINE HYDROCHLORIDE 135 MG

מסלול נתינה (של תרופות):

PER OS

סוג מרשם:

Not required

תוצרת:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

קבוצה תרפויטית:

MEBEVERINE

איזור תרפויטי:

MEBEVERINE

סממני תרפויטית:

Irritable bowel syndrome and conditions included in this group such as: Chronic irritable colon, Gastro- intestinal spasm secondary to organic diseases

תאריך אישור:

2023-08-31

עלון מידע

Pregnancy and breastfeeding:
∙ If you are pregnant or plan to become
pregnant, consult the doctor. Colotal is
not recommended during pregnancy. The
doctor may advise you to stop treatment
with Colotal or to take a different medicine.
∙ If
you
are
breastfeeding
or
start
to
breastfeed, consult the doctor. Colotal is
not recommended when breastfeeding.
The doctor may advise discontinuing
breastfeeding or recommend taking a
different medicine if you are interested in
breastfeeding.
Driving and using machinery:
As far as is known, Colotal does not have an
effect on driving or the use of machines.
Important information about some of the
ingredients of the medicine:
The medicine contains lactose and sucrose.
In case of an intolerance to certain sugars,
consult the doctor before starting treatment.
3. HOW SHOULD YOU USE THE
MEDICINE?
∙ Check with the doctor or pharmacist if
you are uncertain about the dosage and
treatment regimen of the preparation.
- The usual dosage is one tablet 3 times
a day.
- Do not exceed the recommended
dosage.
Method of administration:
- Take one tablet with a full glass of water.
- It is recommended to take the tablet
approximately 20 minutes before the meal.
- Try to take the tablets at set times each day
and at equal intervals so that administration
of the tablets will be spread across the day.
- Do not chew, crush or halve the tablet.
If you accidentally took an overdose or if a
child has accidentally swallowed the medicine,
immediately refer to a doctor or proceed to
a hospital emergency room and bring the
package of the medicine with you.
If you forgot to take this medicine at the
designated time do not take a double dose.
Take the next dose at the scheduled time.
DO NOT TAKE MEDICINES IN THE DARK! CHECK
the label and the dose each time you take
the medicine. Wear glasses if you need
them.
If you have further questions regarding
the use of the medicine, consult the
doctor or pharmacist.
4. SIDE EFFECTS
As with any medicine, use of Colotal may
cause side effects in some users. Do not

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1.
Name of the medicinal product
Colotal tablets 135 mg
2.
Qualitative and quantitative composition
One coated tablet contains 135 mg mebeverine hydrochloride.
Each tablet Duspatal 135 mg contains 79 mg sucrose and 97 mg lactose
monohydrate.
For the full list of excipients see section 6.1
3.
Pharmaceutical form
coated tablets.
4.
Clinical particulars
4.1
Therapeutic indications
Irritable bowel syndrome and conditions included in this group such
as:
chronic irritable colon, gastro-intestinal spasm secondary to organic
diseases
_ _
4.2
Posology and method of administration
_Adults _
Colotal tablets should be swallowed with a sufficient amount of water
(at least
100 ml water). Do not chew.
One 135 mg tablet three times daily; to be given approx. 20 minutes
before
meals.
_ _
_Paediatric Population _
Colotal 135 mg tablets are not recommended for use in children and
adolescents
below 18, due to insufficient data on safety and efficacy.
4.3
Contra-indications
Hypersensitivity to the active substance or to any of the excipients
(see
section 6.1).
4.4
Special warnings and precautions for use
Since Colotal tablets 135 mg contain lactose, patients with rare
hereditary
problems of galactose intolerance, the Lapp lactase deficiency or
glucose-
galactose malabsorption should not take this medicine.
Since Colotal tablets 135 mg contain sucrose, patients with rare
hereditary
problems of fructose intolerance, glucose-galactose malabsorption or
sucrase-isomaltase insufficiency should not take this medicine.
4.5
Interactions with other medicaments and other forms of
interaction
No interactions of mebeverine are known.
4.6
Fertility, pregnancy and lactation
_Pregnancy _
There are no or limited amount of data from the use of mebeverine in
pregnant women.
Animal studies are insufficient with respect to reproductive toxicity
(see
section 5.3). Colotal is not recommended during pregnancy.
_Lactation _
It is unknown whether mebeverine or its metaboliltes are excreted in
human
milk. The excretion of meb